Merge—iConnect Enterprise Archives with Tier 2 Storage: May Exhibit Unrecoverable Loss of Data

April 27, 2016 | Risk Management News

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​​​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a March 28, 2016, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Merge states that the above systems may exhibit an unrecoverable loss of data. This can occur if a study has purged from tier 1 storage (i.e., via high water mark) and only resides in tier 2 and then the study is requested to be updated. Merge further states that in a tiered storage environment older data (less frequently accessed data) is staged to a second storage tier for long term storage. This frees up space on the first storage tier for newer data. In rare circumstances, where the data that exists only on the second tier needs to be accessed, a software problem could lead to data being purged from both the first and second tier, potentially resulting in data loss. This may result in an archived study not being available for future viewing (e.g.., as a previous study for comparison purposes). If previous studies are not available for viewing, this may lead to a delay in treatment in determining the progression of the disease. The manufacturer has not confirmed the...

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